Relestat, 0.5 mg/ml, eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Epinastine hydrochloride

Available from:

Allergan Pharmaceuticals Ireland

ATC code:

S01GX; S01GX10

INN (International Name):

Epinastine hydrochloride

Dosage:

0.5 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antiallergics; epinastine

Authorization status:

Marketed

Authorization date:

2003-08-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
RELESTAT, 0.5 MG/ML, EYE DROPS,
SOLUTION
Epinastine
hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Relestat is and what it is used for
2. What you need to know before you use Relestat
3. How to use Relestat
4. Possible side effects
5. How to store Relestat
6. Contents of the pack and other information
1. WHAT RELESTAT IS AND WHAT IT IS USED FOR
Relestat is an anti-allergic medicine.
It is an eye drops solution used to treat the
SYMPTOMS
of seasonal
ALLERGIC CONJUNCTIVITIS
, a
seasonal allergic disease affecting the eye. The main symptoms treated
by Relestat include
watery eyes and eyes or eyelids which are itchy, red or swollen.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE RELESTAT
DO NOT USE RELESTAT:
•
IF YOU ARE ALLERGIC
to epinastine hydrochloride or any of the other ingredients of this
medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Relestat.
•
IF YOU WEAR SOFT CONTACT LENSES
: you must remove them before using the Relestat eye drops.
After using Relestat, wait at least 15 minutes before putting your
lenses back in. See also
in
Section 2, “Relestat contains benzalkonium chloride”.
•
IF YOU HAVE TO USE ANY OTHER EYE DROPS DURING TREATMENT WITH RELESTAT
: leave at least 10
minutes between putting in Relestat and the other drops.
OTHER MEDICINES AND RELESTAT
Tell your doctor or pharmacist if you are using, have recently used or
might use any other
medicines.
If you have to use a

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2021
CRN009Y0P
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Relestat, 0.5 mg/ml, eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops, solution, contains 0.5 mg of epinastine
hydrochloride. (equivalent to 0.436 mg epinastine)
Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml and
phosphate 4.75 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
A clear colourless sterile solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the symptoms of seasonal allergic conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults is one drop instilled in each affected
eye twice daily, during the symptomatic period.
There is no experience in clinical studies with the use of Relestat
for more than 8 weeks.
_Older people_
Relestat has not been studied in older people. Post-marketing safety
data from the tablet formulation of epinastine
hydrochloride (up to 20 mg once daily) indicates that there are no
particular safety issues for older people compared with adult
patients. As such, no dosage adjustment is considered to be necessary.
_Paediatric population_
The safety and efficacy in children ≥ 12 years has been established
in clinical trials. Relestat may be used in adolescents (12
years of age and older) at the same dosage as in adults.
The safety and efficacy of Relestat in children aged less than 3 years
have not been established. No data are available. There
are limited data on the safety in children aged 3-12 years, described
in section 5.1.
_Patients with hepatic impairment_
Relestat has not been studied in patients with hepatic impairment.
Post‑marketing safety data from the tablet formulation of
epinastine hydrochloride (up to 20 mg once daily) indicates that the
incidence of adverse reactions was higher in this group
compared with adult patients without hepatic impairment. The daily
dose of